LUCINA-MELODI

Pump, Breast, Powered

GENADYNE BIOTECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Genadyne Biotechnologies, Inc. with the FDA for Lucina-melodi.

Pre-market Notification Details

Device IDK112856
510k NumberK112856
Device Name:LUCINA-MELODI
ClassificationPump, Breast, Powered
Applicant GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville,  NY  11801
ContactChien-ming Goh
CorrespondentChien-ming Goh
GENADYNE BIOTECHNOLOGIES, INC. 16 MIDLAND AVE Hicksville,  NY  11801
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-30
Decision Date2012-05-10
Summary:summary

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